Lab Supervisor/ Technical Manager

ABOUT THE ROLE

Precision is building an ISO/IEC 17025-accredited analytical testing laboratory serving 503B pharmaceutical outsourcing facilities, with a focus on peptide identity, purity, potency, and sterility testing.

We're looking for a Lab Supervisor / Technical Manager to own the lab's technical operations and lead our ISO/IEC 17025 accreditation build-out from the ground up. This is a foundational hire—you'll help shape the lab's quality system, method validation program, and technical team as we grow.

WHAT YOU'LL DO

• Serve as the laboratory's Technical Manager under ISO/IEC 17025, with authority over method development, method validation/verification, and technical decision-making that affects the validity of test results.
• Supervise day-to-day laboratory operations, including HPLC and LC-MS-based identity, purity, and potency testing, plus endotoxin and sterility testing per USP <71>, <85>, and related chapters.
• Own instrument qualification (IQ/OQ/PQ), calibration schedules, and equipment traceability records.
• Develop and maintain the competence requirements, training records, and authorization documentation required under ISO/IEC 17025 Clause 6.2 for all laboratory personnel.
• Lead the lab through internal audits, management review, and the on-site accreditation assessment; serve as the primary technical point of contact with the accrediting body (A2LA or ANAB).
• Review and authorize test reports and Certificates of Analysis prior to release.
• Ensure laboratory practices align with 21 CFR Parts 210/211 (cGMP), 21 CFR Part 11 (data integrity), and ICH Q2(R1) method validation standards.
• Supervise and mentor analytical chemists and lab technicians; manage staffing, scheduling, and performance.
• Support proficiency testing program participation and nonconformance/corrective action investigations.

REQUIRED QUALIFICATIONS

• Master's degree in Chemistry, Biochemistry, Analytical Chemistry, or a closely related life science.
• Minimum of 5 years of hands-on analytical laboratory experience, including HPLC and/or LC-MS method development and validation.
• Direct experience working within an ISO/IEC 17025 quality management system or a comparable regulated quality system (cGMP, GLP).
• Demonstrated experience with instrument qualification, calibration, and traceability documentation.
• Strong working knowledge of USP compendial testing methods, including <71>, <85>, <61>/<62>, <905>, and <1225>/<1226>.
• Prior supervisory or team-lead experience in a laboratory setting.
• Excellent technical writing skills for SOPs, validation protocols, and audit-ready documentation.

PREFERRED QUALIFICATIONS

• Experience specifically with peptide analytical chemistry, including identity confirmation, sequence verification, and impurity/degradant profiling.
• Prior experience supporting or leading an ISO/IEC 17025 accreditation process from application through on-site assessment.
• Familiarity with 503A/503B compounding pharmacy regulatory requirements.
• Experience serving as a laboratory Quality Manager or Technical Manager of record.

WORK ENVIRONMENT & PHYSICAL REQUIREMENTS

• Laboratory environment requiring standing for extended periods and use of personal protective equipment.
• Some work will occur in a controlled/classified space, including sterility and microbial testing.
• Occasional evening/weekend availability during accreditation assessments or urgent testing turnarounds.

Pay: $60,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person